| FEMALE | MALE | P-value | Overall | |
|---|---|---|---|---|
| (N=1373) | (N=1321) | (N=2694) | ||
| age | ||||
| Mean (SD) | 38.7 (3.34) | 38.6 (3.18) | 0.309 | 38.6 (3.26) |
| Median [Min, Max] | 38.6 [31.0, 46.6] | 38.5 [31.5, 46.7] | 38.6 [31.0, 46.7] | |
| RACE_SOURCE_VALUE | ||||
| asian | 112 (8.2%) | 100 (7.6%) | 0.665 | 212 (7.9%) |
| black | 175 (12.7%) | 163 (12.3%) | 338 (12.5%) | |
| hispanic | 214 (15.6%) | 221 (16.7%) | 435 (16.1%) | |
| native | 6 (0.4%) | 8 (0.6%) | 14 (0.5%) | |
| other | 2 (0.1%) | 0 (0%) | 2 (0.1%) | |
| white | 864 (62.9%) | 829 (62.8%) | 1693 (62.8%) |
Executive summary: NSAID Drug Initiation Analysis
Conducted exploratory analysis on patients initiating NSAIDs using synthetic OMOP CDM v5.4 database. NSAID cohort defined as Cohort_Definition_ID=4.
Key aspects analyzed:
Demographics:
- Age and gender distribution
- Baseline drug use
- Baseline conditions
- Post-index outcomes, particularly GI bleeding (Condition Concept ID 192671)
Methodology:
- Used Quarto for dynamic reporting
- Created visual representations for clarity
- Organized code and documentation in GitHub repository
Analysis provides insights into NSAID initiation patterns and potential outcomes, contributing to healthcare analytics discussions on NSAID safety.
Study population
There are 2,694 patients in the cohort who initiated NSAID use.
Table 1. Characteristics of patients using NSAIDs
Drug use at baseline
On average, patients took 9 medications.
Table 2. NSAIDs used in patients
| DRUG_NAME | COUNT | PERCENTAGE (%) |
|---|---|---|
| Aspirin | 1919 | 71.2 |
| celecoxib | 1844 | 68.4 |
| Ibuprofen | 856 | 31.8 |
| Diclofenac | 850 | 31.6 |
| Naproxen | 329 | 12.2 |
Table 3. List of drugs used (excluding NSAIDs)
| DRUG_NAME | COUNT | PERCENTAGE (%) |
|---|---|---|
| Acetaminophen | 2628 | 97.6 |
| Amoxicillin | 1756 | 65.2 |
| Clavulanate | 1662 | 61.7 |
| Penicillin V | 1532 | 56.9 |
| Dextromethorphan | 1051 | 39.0 |
| Doxylamine | 1051 | 39.0 |
| Penicillin G | 826 | 30.7 |
| Inert Ingredients | 682 | 25.3 |
| Norethindrone | 628 | 23.3 |
| Mestranol | 605 | 22.5 |
| Doxycycline | 449 | 16.7 |
| Ampicillin | 425 | 15.8 |
| Nitrofurantoin | 379 | 14.1 |
| Phenazopyridine | 379 | 14.1 |
| Ethinyl Estradiol | 274 | 10.2 |
| norgestimate | 255 | 9.5 |
| Meperidine | 214 | 7.9 |
| Oxycodone | 199 | 7.4 |
| Hydrocodone | 193 | 7.2 |
| fluticasone | 148 | 5.5 |
| Cefaclor | 121 | 4.5 |
| Prednisone | 118 | 4.4 |
| Diphenhydramine | 105 | 3.9 |
| Hydrocortisone | 105 | 3.9 |
| Albuterol | 101 | 3.7 |
| Epinephrine | 100 | 3.7 |
| Chlorpheniramine | 75 | 2.8 |
| Cefuroxime | 74 | 2.7 |
| Atropine | 72 | 2.7 |
| Methylphenidate | 66 | 2.4 |
| Ferrous fumarate | 62 | 2.3 |
| Amiodarone | 60 | 2.2 |
| Medroxyprogesterone | 53 | 2.0 |
| Diazepam | 51 | 1.9 |
| salmeterol | 48 | 1.8 |
| Simvastatin | 41 | 1.5 |
| Nitroglycerin | 40 | 1.5 |
| Carbamazepine | 39 | 1.4 |
| Levonorgestrel | 34 | 1.3 |
| Amlodipine | 33 | 1.2 |
| clopidogrel | 31 | 1.2 |
| Astemizole | 26 | 1.0 |
| Morphine | 24 | 0.9 |
| Ondansetron | 24 | 0.9 |
| Piperacillin | 24 | 0.9 |
| Propofol | 24 | 0.9 |
| Rocuronium | 24 | 0.9 |
| Sodium Chloride | 24 | 0.9 |
| heparin | 24 | 0.9 |
| tazobactam | 24 | 0.9 |
| Midazolam | 23 | 0.9 |
| Isoflurane | 17 | 0.6 |
| alteplase | 16 | 0.6 |
| remifentanil | 12 | 0.4 |
| Vitamin B 12 | 10 | 0.4 |
| fexofenadine | 10 | 0.4 |
| Etonogestrel | 8 | 0.3 |
| Loratadine | 8 | 0.3 |
| Cyclosporine | 7 | 0.3 |
| Terfenadine | 7 | 0.3 |
| desflurane | 5 | 0.2 |
| drospirenone | 5 | 0.2 |
| Alfentanil | 4 | 0.1 |
| Fentanyl | 4 | 0.1 |
| Sufentanil | 4 | 0.1 |
| Cetirizine | 3 | 0.1 |
| ferrous sulfate | 3 | 0.1 |
| norelgestromin | 3 | 0.1 |
| Methotrexate | 2 | 0.1 |
| atorvastatin | 2 | 0.1 |
| sevoflurane | 2 | 0.1 |
| Lorazepam | 1 | 0.0 |
Baseline conditions
Allergies
There were 525 patients in the OBSERVATION dataset. Below is a table of their previous allergies. No patients were allergic to NSAIDs.
Table 4. Allergies of patients
| OBS_NAME | COUNT | PERCENTAGE (%) |
|---|---|---|
| Allergy to mold | 304 | 11.3 |
| Allergy to animal dander | 298 | 11.1 |
| History of appendectomy | 244 | 9.1 |
| Allergy to grass pollen | 220 | 8.2 |
| Allergy to tree pollen | 216 | 8.0 |
| Allergy to house dust mite | 206 | 7.6 |
| Shellfish allergy | 186 | 6.9 |
| Allergy to mildew | 152 | 5.6 |
| Allergy to mould | 152 | 5.6 |
| Animal dander allergy | 149 | 5.5 |
| Dander allergy | 149 | 5.5 |
| History of cardiac arrest | 144 | 5.3 |
| History of single seizure | 134 | 5.0 |
| History of appendicectomy | 122 | 4.5 |
| Allergy to hay | 110 | 4.1 |
| House dust mite allergy | 103 | 3.8 |
| Allergy to peanuts | 100 | 3.7 |
| Allergy to bee venom | 84 | 3.1 |
| Latex allergy | 80 | 3.0 |
| Allergy to wheat | 76 | 2.8 |
| Allergy to eggs | 74 | 2.7 |
| Allergy to fish | 72 | 2.7 |
| History of one seizure ever | 67 | 2.5 |
| Allergy to nut | 66 | 2.4 |
| Allergy to dairy product | 64 | 2.4 |
| Nut allergy | 33 | 1.2 |
| Allergy to soy | 22 | 0.8 |
| Allergy to soya | 11 | 0.4 |
| History of myocardial infarction | 10 | 0.4 |
| Past history of myocardial infarction | 5 | 0.2 |
| Attempted suicide - cut/stab | 2 | 0.1 |
Conditions at baseline
There were 73 unique conditions for patients using NSAIDs in the CONDITION_ERA datasets. On average, people had 10 conditions.
Table 5. Conditions of patients using NSAIDs at baseline
| CONDITION_NAME | COUNT | PERCENTAGE (%) |
|---|---|---|
| Osteoarthritis | 2694 | 100.0 |
| Viral sinusitis | 2658 | 98.7 |
| Acute viral pharyngitis | 2463 | 91.4 |
| Acute bronchitis | 2346 | 87.1 |
| Otitis media | 1979 | 73.5 |
| Streptococcal sore throat | 1431 | 53.1 |
| Sprain of ankle | 1074 | 39.9 |
| Peptic ulcer | 802 | 29.8 |
| Concussion with no loss of consciousness | 642 | 23.8 |
| Sinusitis | 583 | 21.6 |
| Chronic sinusitis | 571 | 21.2 |
| Acute bacterial sinusitis | 535 | 19.9 |
| Sprain of wrist | 524 | 19.5 |
| Whiplash injury to neck | 485 | 18.0 |
| Ulcerative colitis | 413 | 15.3 |
| Esophagitis | 409 | 15.2 |
| Diverticular disease | 405 | 15.0 |
| Angiodysplasia of stomach | 388 | 14.4 |
| Polyp of colon | 380 | 14.1 |
| Fracture of forearm | 372 | 13.8 |
| Fracture of clavicle | 333 | 12.4 |
| Fracture subluxation of wrist | 331 | 12.3 |
| Laceration of foot | 327 | 12.1 |
| Facial laceration | 314 | 11.7 |
| Laceration of forearm | 313 | 11.6 |
| Fracture of ankle | 311 | 11.5 |
| Laceration of thigh | 307 | 11.4 |
| Laceration of hand | 302 | 11.2 |
| No matching concept | 258 | 9.6 |
| Child attention deficit disorder | 253 | 9.4 |
| Escherichia coli urinary tract infection | 242 | 9.0 |
| First degree burn | 236 | 8.8 |
| Concussion with loss of consciousness | 178 | 6.6 |
| Cystitis | 178 | 6.6 |
| Fracture of rib | 177 | 6.6 |
| Injury of tendon of the rotator cuff of shoulder | 163 | 6.1 |
| Second degree burn | 140 | 5.2 |
| Appendicitis | 122 | 4.5 |
| Acute allergic reaction | 115 | 4.3 |
| Contact dermatitis | 113 | 4.2 |
| Childhood asthma | 96 | 3.6 |
| Perennial allergic rhinitis with seasonal variation | 79 | 2.9 |
| Cardiac arrest | 72 | 2.7 |
| Closed fracture of hip | 69 | 2.6 |
| Seizure disorder | 67 | 2.5 |
| Injury of medial collateral ligament of knee | 66 | 2.4 |
| Perennial allergic rhinitis | 64 | 2.4 |
| Anemia | 63 | 2.3 |
| Coronary arteriosclerosis | 59 | 2.2 |
| Atopic dermatitis | 54 | 2.0 |
| Injury of anterior cruciate ligament | 54 | 2.0 |
| Tear of meniscus of knee | 54 | 2.0 |
| Concussion injury of brain | 52 | 1.9 |
| Rupture of patellar tendon | 44 | 1.6 |
| Pulmonary emphysema | 35 | 1.3 |
| Rupture of appendix | 31 | 1.2 |
| Bullet wound | 27 | 1.0 |
| Seasonal allergic rhinitis | 25 | 0.9 |
| Acute cholecystitis | 24 | 0.9 |
| Cerebrovascular accident | 24 | 0.9 |
| Emphysematous bronchitis | 24 | 0.9 |
| Epilepsy | 24 | 0.9 |
| Gallstone | 24 | 0.9 |
| Recurrent urinary tract infection | 20 | 0.7 |
| Traumatic brain injury | 20 | 0.7 |
| Third degree burn | 14 | 0.5 |
| Fracture of vertebral column without spinal cord injury | 12 | 0.4 |
| Rheumatoid arthritis | 6 | 0.2 |
| Asthma | 5 | 0.2 |
| Myocardial infarction | 5 | 0.2 |
| Pyelonephritis | 4 | 0.1 |
| Chronic paralysis due to lesion of spinal cord | 3 | 0.1 |
| Fracture of vertebral column with spinal cord injury | 3 | 0.1 |
Compare conditions by gender
Post-index
Table 6. Conditions post-index in patients using NSAIDs
| CONDITION_NAME | COUNT | PERCENTAGE (%) |
|---|---|---|
| Viral sinusitis | 2066 | 76.7 |
| Acute viral pharyngitis | 1664 | 61.8 |
| Acute bronchitis | 1515 | 56.2 |
| Streptococcal sore throat | 536 | 19.9 |
| Gastrointestinal hemorrhage | 479 | 17.8 |
| Sprain of ankle | 478 | 17.7 |
| Sinusitis | 315 | 11.7 |
| Acute bacterial sinusitis | 312 | 11.6 |
| Concussion with no loss of consciousness | 282 | 10.5 |
| Whiplash injury to neck | 267 | 9.9 |
| Chronic sinusitis | 251 | 9.3 |
| Cerebrovascular accident | 200 | 7.4 |
| Sprain of wrist | 188 | 7.0 |
| Escherichia coli urinary tract infection | 183 | 6.8 |
| Laceration of hand | 177 | 6.6 |
| Osteoporosis | 171 | 6.3 |
| No matching concept | 169 | 6.3 |
| Laceration of thigh | 167 | 6.2 |
| Laceration of forearm | 164 | 6.1 |
| Fracture of forearm | 161 | 6.0 |
| Facial laceration | 158 | 5.9 |
| Otitis media | 154 | 5.7 |
| Atrial fibrillation | 137 | 5.1 |
| First degree burn | 137 | 5.1 |
| Laceration of foot | 135 | 5.0 |
| Coronary arteriosclerosis | 132 | 4.9 |
| Fracture subluxation of wrist | 129 | 4.8 |
| Fracture of ankle | 128 | 4.8 |
| Fracture of clavicle | 124 | 4.6 |
| Alzheimer's disease | 117 | 4.3 |
| Cystitis | 115 | 4.3 |
| Injury of tendon of the rotator cuff of shoulder | 93 | 3.5 |
| Second degree burn | 81 | 3.0 |
| Concussion with loss of consciousness | 80 | 3.0 |
| Fracture of rib | 77 | 2.9 |
| Cardiac arrest | 66 | 2.4 |
| Closed fracture of hip | 65 | 2.4 |
| Myocardial infarction | 62 | 2.3 |
| Pathological fracture due to osteoporosis | 56 | 2.1 |
| Pneumonia | 52 | 1.9 |
| Injury of medial collateral ligament of knee | 43 | 1.6 |
| Pulmonary emphysema | 42 | 1.6 |
| Anemia | 39 | 1.4 |
| Appendicitis | 35 | 1.3 |
| Rupture of patellar tendon | 35 | 1.3 |
| Hypothyroidism | 31 | 1.2 |
| Tear of meniscus of knee | 28 | 1.0 |
| Injury of anterior cruciate ligament | 26 | 1.0 |
| Emphysematous bronchitis | 24 | 0.9 |
| Bullet wound | 19 | 0.7 |
| Familial Alzheimer's disease of early onset | 19 | 0.7 |
| Concussion injury of brain | 18 | 0.7 |
| Recurrent urinary tract infection | 13 | 0.5 |
| Rheumatoid arthritis | 12 | 0.4 |
| Seizure disorder | 12 | 0.4 |
| Acute cholecystitis | 11 | 0.4 |
| Fracture of vertebral column without spinal cord injury | 11 | 0.4 |
| Gallstone | 11 | 0.4 |
| Rupture of appendix | 10 | 0.4 |
| Third degree burn | 10 | 0.4 |
| Traumatic brain injury | 7 | 0.3 |
| Epilepsy | 6 | 0.2 |
| Pyelonephritis | 5 | 0.2 |
| Acute allergic reaction | 2 | 0.1 |
Compare conditions pre- and post- index:
Patients with GI Bleed
The incidence of GI bleeding increased from 0% to 18% following NSAID initiation.
Table 7. Conditions that have increased post-NSAID use.
| CONDITION_NAME | COUNT_PRE | COUNT_POST | PERCENTAGE_INCREASE |
|---|---|---|---|
| Alzheimer's disease | 0 | 117 | 4.3 |
| Atrial fibrillation | 0 | 137 | 5.1 |
| Cerebrovascular accident | 24 | 200 | 6.5 |
| Coronary arteriosclerosis | 59 | 132 | 2.7 |
| Familial Alzheimer's disease of early onset | 0 | 19 | 0.7 |
| Gastrointestinal hemorrhage | 0 | 479 | 17.8 |
| Hypothyroidism | 0 | 31 | 1.2 |
| Myocardial infarction | 5 | 62 | 2.1 |
| Osteoporosis | 0 | 171 | 6.3 |
| Pathological fracture due to osteoporosis | 0 | 56 | 2.1 |
| Pneumonia | 0 | 52 | 1.9 |
| Pulmonary emphysema | 35 | 42 | 0.3 |
| Pyelonephritis | 4 | 5 | 0.0 |
| Rheumatoid arthritis | 6 | 12 | 0.2 |
Future analysis
Our analysis has provided valuable insights into NSAID initiation and its correlation with GI bleeding. However, to gain a more comprehensive understanding, I propose further investigation into the following areas:
Drug Strength and Duration of Use: Analyze the impact of NSAID dosage and treatment length on GI bleeding risk, including time-to-event analysis.
Adherence to Treatment: Evaluate patient compliance using pharmacy refill data and its relationship to adverse events.
Specific NSAID types: Compare the risk profiles of different NSAID types (e.g., ibuprofen, naproxen, diclofenac) to identify if certain drugs carry higher risks.
Healthcare utilization patterns: Examine how factors like frequency of doctor visits or hospitalizations correlate with NSAID use and GI bleeding events.
Long-term outcomes: Conduct a longitudinal study to assess long-term consequences of NSAID use and GI bleeding events on patient health and quality of life.
These additional analyses will provide a deeper understanding of NSAID-related risks and inform strategies to enhance patient safety and optimize prescribing practices.